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Serving 500+ biopharmaceutical companies globally:

Teva
Johnson and Johnson
Fuji
Cantor Fitzgerald
Farmers Insurance
Baxter
Dow
Federal Trade Commission
Argus Health
Colorcon

Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020883

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NDA 020883 describes ARGATROBAN, which is a drug marketed by Fresenius Kabi Usa, Hospira Inc, Mylan Institutional, Hikma Pharm Co Ltd, Par Sterile Products, Pfizer, Teva Pharms Usa, Sandoz, Eagle Pharms, and Gland Pharma Ltd, and is included in eleven NDAs. It is available from five suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ARGATROBAN profile page.

The generic ingredient in ARGATROBAN is argatroban. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the argatroban profile page.

Summary for NDA: 020883

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 020883

Mechanism of ActionThrombin Inhibitors

Suppliers and Packaging for NDA: 020883

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARGATROBAN
argatroban
INJECTABLE;INJECTION 020883 NDA GlaxoSmithKline LLC 0007-4407 0007-4407-01 1 VIAL in 1 CARTON (0007-4407-01) > 2.5 mL in 1 VIAL
ARGATROBAN
argatroban
INJECTABLE;INJECTION 020883 NDA GlaxoSmithKline LLC 0007-4407 0007-4407-54 1 VIAL in 1 CARTON (0007-4407-54) > 2.5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MG/2.5ML (100MG/ML)
Approval Date:Jun 30, 2000TE:APRLD:Yes

Expired Orange Book Patents for NDA: 020883

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
ARGATROBAN
argatroban
INJECTABLE;INJECTION020883-001Jun 30, 20005,214,052► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Accenture
Queensland Health
Julphar
Teva
Medtronic
Deloitte
Novartis
UBS
McKesson
Chubb

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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